Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry

Running, not enrolling

Conditions studied: Uterine Fibroids

In brief

The ULTRA Registry is a nationwide observational arm of the ULTRA trial. Data from the ULTRA Registry will be used to evaluate the long-term safety and efficacy of laparoscopic RF ablation (Acessa). The ULTRA Registry will recruit women age 21 or older who plan to undergo or have undergone laparoscopic RF ablation (Acessa) or myomectomy within the United States. Participants will be recruited through study materials distributed at clinical offices across the country where gynecologists are performing laparoscopic RF ablation (Acessa). Study participants will consent to participate in a 3 year prospective study conducted by UCSF but the fibroid procedure will be performed by the study participants' own gynecologist. We will evaluate changes in fibroid-related symptoms from pre-treatment values to 6, 12, 18, 24, 30, and 36 months after RFA (Acessa). We will determine long-term efficacy of RFA (Acessa) by evaluating the rate of re-treatment for symptomatic fibroids after the RFA (Acessa) procedure versus myomectomy. Participants will be asked for permission to review their medical records to assess surgical and pregnancy outcomes. UC San Francisco will have oversight of all scientific and administrative aspects of the study. All study data will be stored securely in a HIPAA compliant, secure database monitored by the UC San Francisco Coordinating Center.

Key facts

Study ID

NCT02100904

Run by

University of California, San Francisco

People needed

578

Starts

2014-05-01

Expected to finish

2026-06-30

Last updated by the study team

2026-04-27

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Planning to undergo or have undergone* RF ablation (Acessa) or myomectomy (laparoscopic or abdominal) for treatment of uterine fibroids.
• Able to give informed consent
• Speak English or Spanish
• Women enrolled at contracted clinical sites must enroll prior to their RF ablation treatment

You may not qualify if…

• <21 years of age
• Plan to undergo hysteroscopic myomectomy

Where it is running

• UC Irvine Medical Center — Irvine, California, United States
• University of California, San Diego — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Dedicated to Women — Dover, Delaware, United States
• Fibroid and Pelvic Wellness Center of Georgia — Alpharetta, Georgia, United States
• Gynecology Institute of Chicago — Chicago, Illinois, United States
• Women's Healthcare Associates of IL, SC — Homewood, Illinois, United States
• Duke University — Durham, North Carolina, United States
• Tassone Advanced Gynecology — Austin, Texas, United States
• UT Southwestern — Dallas, Texas, United States
• MacArthur Medical Center — Irving, Texas, United States
• Acacia OBGYN — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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